Market Authorization

 
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2014/3/10
NEW YORK, March 10, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the "Company") today announced it has submitted a Marketing Authorization Application ("MAA") to the European Medicines Agency ("EMA"), seeking the approval of Zerenex™ (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease ("CKD"), including dialysis- and non-dialysis dependent CKD.
Sign-up for Keryx Biopharmaceuticals Announces Submission of a Marketing Authorization Application for Zerenex(TM) to the European Medicines Agency investment picks
OPKO Health, Inc. (NYSE: OPK) announced that its Barcelona, Spain subsidiary, Pharmadiet, S.L.U. (“Pharmadiet”), received final marketing approval from Spain's health authority (Agencia Española de Medicamentos y Productos Sanitarios) for commercialization of its oral and injectable formulations of citicoline.
Sign-up for OPKO Obtains Final Marketing Authorization for Citicoline in Spain investment picks
2014/1/8
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Medicines Agency (EMA) has validated the company’s marketing authorization application (MAA) for the use of daclatasvir (DCV), an investigational NS5A complex inhibitor, for the treatment of adults with chronic hepatitis C (HCV) with compensated liver disease, including genotypes 1, 2, 3, and 4.
Sign-up for Daclatasvir Marketing Authorization Application for Treatment of Chronic Hepatitis C Validated for Accelerated Regulatory Review by the European Medicines Agency investment picks
2014/4/2
NEW YORK, April 2, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the "Company") today announced that the European Medicines Agency ("EMA") has determined that the Company's Marketing Authorization Application ("MAA") seeking the approval of Zerenex™ (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease ("CKD"), including dialysis- and non-dialysis-dependent CKD, is valid.
Sign-up for Keryx Biopharmaceuticals Announces EMA Validation of Marketing Authorization Application for Zerenex(TM) investment picks
Cangene receives marketing authorization approval for WinRho 1500 LQ in Portugal Canada NewsWire TSX: CNJ Readers are referred to the cautionary note regarding Forward-looking Information.
Sign-up for Cangene receives marketing authorization approval for WinRho 1500 LQ in Portugal investment picks
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed Takeda Pharmaceutical Company Limited (Takeda)’s announcement that the European Commission has granted Marketing Authorization (MA) for VIPIDIA™ (alogliptin) for the treatment of Type 2 diabetes patients who are uncontrolled on existing therapies and for the fixed-dose combinations VIPDOMET™ (alogliptin and metformin) and INCRESYNC™ (alogliptin and pioglitazone). The Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), issued a positive opinion for these products on July 26, 2013.
Sign-up for Furiex Confirms Takeda Receives European Marketing Authorization for VIPIDIA™ (alogliptin), VIPDOMET™ (alogliptin and metformin) and INCRESYNC™ (alogliptin and pioglitazone) investment picks
2013/10/4
LONDON-- Drug groups GlaxoSmithKline PLC (GSK.LN) and Genmab A/S (GEN.KO) announced Friday the submission to the European Medicines Agency of a variation to the Marketing Authorization for the use of Arzerra for treatment of Leukaemia patients.
Sign-up for Glaxo Submits Variation to Marketing Authorization for Leukaemia Drug investment picks
2014/1/17
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Sovaldi ® (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection in adults, in combination with other antiviral agents (ribavirin (RBV) and pegylated interferon alpha (peg-IFN)). Today’s marketing authorization follows an accelerated assessment by the European Medicines Agency, a designation that is granted to new medicines of major public health interest, and allows for the marketing of Sovaldi in all 28 countries of the European Union (EU). Sovaldi has been studied in hepatitis C virus (HCV) genotypes 1-6.
Sign-up for European Commission Grants Marketing Authorization for Gilead’s Sovaldi® (Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection investment picks
2014/2/25
Orexigen received CHMP Day 120 List of Questions and expects to submit a timely response; Company continues to have high conviction for a positive CHMP opinion SAN DIEGO , Feb.
Sign-up for Orexigen Provides Update on Its NB32 European Marketing Authorization Application investment picks
2014/2/27
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that the European Medicines Agency (EMA) has accepted for review the Company’s Marketing Authorization Application (MAA) for its investigational antibiotic tedizolid phosphate.
Sign-up for Cubist Announces EMA Acceptance of Tedizolid Marketing Authorization Application for Review investment picks
- European Market Launch Planned for Second Half of 2014 - SEATTLE , Sept.
Sign-up for Omeros Submits OMS302 Marketing Authorization Application to European Medicines Agency investment picks
2013/9/17
September 17, 2013 – Dendreon Corporation (Nasdaq: DNDN) today announced that the European Commission (EC) has granted marketing authorization for PROVENGE ® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) dispersion for infusion in the European Union (EU) for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Sign-up for Dendreon Announces Marketing Authorization for PROVENGE® in the European Union investment picks
2013/8/8
Teva Pharmaceutical Industries Ltd (NYSE: TEVA) announced today that the European Commission has granted marketing authorization for Lonquex ® (lipegfilgrastim). This approval provides the regulatory framework for the commercialization of Lonquex ® in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein.
Sign-up for Teva Receives European Marketing Authorization for Lonquex® (XM22 lipegfilgrastim) investment picks
VILLA GUARDIA, Italy, Oct.
Sign-up for Gentium Receives Marketing Authorization From the European Commission for Defitelio(R) (Defibrotide) investment picks
2013/10/3
- Company is seeking approval for Contrave for the management of obesity - SAN DIEGO , Oct.
Sign-up for Orexigen Therapeutics Submits Contrave Marketing Authorization Application to European Medicines Agency investment picks
2013/12/18
LONDON--Vectura Group PLC (VEC.LN), confirmed Wednesday that its partner Sandoz, the generic pharmaceuticals division of Novartis AG, has received Danish marketing authorization for AirFluSal Forspiro (formerly known as VR315), a new advanced inhaler for patients with asthma and chronic obstructive pulmonary disease.
Sign-up for Vectura Group: Sandoz Gets Danish Marketing Authorization for VR315 investment picks
2013/9/2
SAN DIEGO , Sept.
Sign-up for Halozyme Announces Roche Receives Marketing Authorization for Herceptin SC in European Union investment picks
NOVATO, Calif., Sept.
Sign-up for Raptor Pharmaceutical Receives Marketing Authorization for PROCYSBI(R) in European Union investment picks

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Market Authorization
Name |  Ticker |  Star Rating |  Market Cap |  Stock Type |  Sector |  Industry Star Rating |  Investment Style |  Total Assets |  Category |  Top Holdings |  Top Sectors |  Symbol |  Title Star Rating |  Category |  Total Assets |  Top Holdings |  Top Sectors |  Symbol |  Name Title |  Date |  Author |  Collection |  Interest |  Popularity Name |  Ticker |  Star Rating |  Market Cap |  Stock Type |  Sector |  Industry Star Rating |  Investment Style |  Total Assets |  Category |  Top Holdings |  Top Sectors |  Symbol / Ticker |  Title Star Rating |  Category |  Total Assets |  Symbol / Ticker |  Name Title |  Date |  Author |  Collection |  Popularity |  Interest Title |  Date |  Company |  Symbol |  Interest |  Popularity Title |  Date |  Company |  Symbol |  Interest |  Popularity Topic |  Sector |  Key Indicators |  User Interest |  Market Cap |  Industry |  Topic |  Sector |  Key Indicators |  User Interest |  Market Cap |  Industry

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